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Xifaxan

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Xifaxan

Xifaxan Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Xifaxan is a semi-synthetic antibiotic indicated for the treatment of patients ( ≥ 12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli and for hepatic encephalopathy. Currently, Xifaxan has no FDA approved generic equivalent. Side effects may include nausea, vomiting, bloating, gas, abdominal pain, and people may feel they need to urgently defecate.

Xifaxan (rifaximin) tablets for oral administration are film-coated and contain 200 or 550 mg of rifaximin. Usual dosage is 200 mg three times a day for three days for diarrhea and 550mg twice a day for 3 days for hepatic encephalopathy. Serious side effects include C. difficile diarrhea and continued diarrhea due to organisms resistant to the drug. Caution is suggested when treating severe hepatic encephalopathy as systemic drug toxicity may develop. There are no adequate and well controlled studies of Xifaxan use in pregnancy; the drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known if the drug is present in breast milk. The safety and effectiveness of Xifaxan in pediatric patients with travelers' diarrhea less than 12 years of age have not been established.

Our Xifaxan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Xifaxan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.

Less serious side effects are more likely, and may include:

  • bloating, gas, stomach pain;
  • feeling like you need to empty your bowel urgently;
  • feeling like your bowel is not completely empty;
  • nausea, vomiting, constipation;
  • headache, dizziness;
  • tired feeling; or
  • swelling in your hands, feet, or torso.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xifaxan (Rifaximin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Xifaxan Overview - Patient Information: Side Effects

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Xifaxan (Rifaximin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Xifaxan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Travelers' Diarrhea

The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers' diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic.

Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation.

All adverse reactions for XIFAXAN 200 mg three times daily that occurred at a frequency ≥ 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.)

Table 1: All Adverse Reactions With an Incidence ≥ 2% Among Patients Receiving XIFAXAN Tablets, 200 mg Three Times Daily, in Placebo-Controlled Studies

MedDRA Preferred Term Number (%) of Patients
XIFAXAN Tablets, 600 mg/day
N = 320
Placebo
N = 228
Flatulence 36 (11%) 45 (20%)
Headache 31 (10%) 21 (9%)
Abdominal Pain NOS* 23 (7%) 23 (10%)
Rectal Tenesmus 23 (7%) 20 (9%)
Defecation Urgency 19 (6%) 21 (9%)
Nausea 17 (5%) 19 (8%)
Constipation 12 (4%) 8 (4%)
Pyrexia 10 (3%) 10 (4%)
Vomiting NOS 7 (2%) 4 (2%)
*NOS: Not otherwise specified

The following adverse reactions, presented by body system, have also been reported in < 2% of patients taking XIFAXAN in the two placebo-controlled clinical trials where the 200 mg tablet was taken three times a day for travelers' diarrhea. The following includes adverse reactions regardless of causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Lymphocytosis, monocytosis, neutropenia

Ear and Labyrinth Disorders: Ear pain, motion sickness, tinnitus

Gastrointestinal Disorders: Abdominal distension, diarrhea NOS, dry throat, fecal abnormality NOS, gingival disorder NOS, inguinal hernia NOS, dry lips, stomach discomfort

General Disorders and Administration Site Conditions: Chest pain, fatigue, malaise, pain NOS, weakness

Infections and Infestations: Dysentery NOS, respiratory tract infection NOS, upper respiratory tract infection NOS

Injury and Poisoning: Sunburn

Investigations: Aspartate aminotransferase increased, blood in stool, blood in urine, weight decreased

Metabolic and Nutritional Disorders: Anorexia, dehydration

Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, muscle spasms, myalgia, neck pain

Nervous System Disorders: Abnormal dreams, dizziness, migraine NOS, syncope, loss of taste

Psychiatric Disorders: Insomnia

Renal and Urinary Disorders: Choluria, dysuria, hematuria, polyuria, proteinuria, urinary frequency

Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea NOS, nasal passage irritation, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, rhinitis NOS, rhinorrhea

Skin and Subcutaneous Tissue Disorders: Clamminess, rash NOS, sweating increased

Vascular Disorders: Hot flashes NOS

Hepatic Encephalopathy

The data described below reflect exposure to XIFAXAN 550 mg in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days). The safety of XIFAXAN 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n = 140) and in a long term follow-up study (n = 280). The population studied had a mean age of 56.26 (range: 21-82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black. Ninety-one percent of patients in the trial were taking lactulose concomitantly. All adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in XIFAXAN 550 mg-treated subjects than in the placebo group in the 6-month trial are provided in Table 2. (These include adverse events that may be attributable to the underlying disease).

Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Receiving XIFAXAN and at a Higher Incidence Than Placebo

MedDRA Preferred Term Number (%) of Patients
XIFAXAN Tablets 550 mg TWICE DAILY
N = 140
Placebo
N = 159
Edema peripheral 21 (15%) 13 (8%)
Nausea 20 (14%) 21 (13%)
Dizziness 18 (13%) 13 (8%)
Fatigue 17 (12%) 18 (11%)
Ascites 16 (11%) 15 (9%)
Muscle spasms 13 (9%) 11 (7%)
Pruritus 13 (9%) 10 (6%)
Abdominal pain 12 (9%) 13 (8%)
Abdominal distension 11 (8%) 12 (8%)
Anemia 11 (8%) 6 (4%)
Cough 10 (7%) 11 (7%)
Depression 10 (7%) 8 (5%)
Insomnia 10 (7%) 11 (7%)
Nasopharyngitis 10 (7%) 10 (6%)
Abdominal pain upper 9 (6%) 8 (5%)
Arthralgia 9 (6%) 4 (3%)
Back pain 9 (6%) 10 (6%)
Constipation 9 (6%) 10 (6%)
Dyspnea 9 (6%) 7 (4%)
Pyrexia 9 (6%) 5 (3%)
Rash 7 (5%) 6 (4%)

The following adverse reactions, presented by body system, have also been reported in the placebo-controlled clinical trial in greater than 2% but less than 5% of patients taking XIFAXAN 550 mg taken orally two times a day for hepatic encephalopathy. The following includes adverse events occurring at a greater incidence than placebo, regardless of causal relationship to drug exposure.

Ear and Labyrinth Disorders: Vertigo

Gastrointestinal Disorders: Abdominal pain lower, abdominal tenderness, dry mouth, esophageal variceal bleed, stomach discomfort

General Disorders and Administration Site Conditions: Chest pain, generalized edema, influenza like illness, pain NOS

Infections and Infestations: Cellulitis, pneumonia, rhinitis, upper respiratory tract infection NOS

Injury, Poisoning and Procedural Complications: Contusion, fall, procedural pain

Investigations: Weight increased

Metabolic and Nutritional Disorders: Anorexia, dehydration, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia

Musculoskeletal, Connective Tissue, and Bone Disorders: Myalgia, pain in extremity

Nervous System Disorders: Amnesia, disturbance in attention, hypoesthesia, memory impairment, tremor

Psychiatric Disorders: Confusional state

Respiratory, Thoracic, and Mediastinal Disorders: Epistaxis

Vascular Disorders: Hypotension

Postmarketing Experience

The following adverse reactions have been identified during post approval use of XIFAXAN. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to XIFAXAN.

Infections and Infestations

Cases of C. difficile-associated colitis have been reported [see WARNINGS AND PRECAUTIONS].

General

Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported. These events occurred as early as within 15 minutes of drug administration.

Read the entire FDA prescribing information for Xifaxan (Rifaximin) »

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Xifaxan - User Reviews

Xifaxan User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Xifaxan sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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